Just Say No to FDA’s Idea of Transparency from MD&DI Magazine Aug-10 http://ht.ly/2sa6c See our post FDA Issue Assessment of 510(k) for the FDA assessment report on the 510(k) process
Device Industry Critic to Join CDRH as 1st Deputy Dir of Science?
Device Industry Critic to Join CDRH as first Deputy Director of Science? – From Medical Device Summit http://ht.ly/2s5c0
New Zealand: Draft Recall Proc Medicines & Medical Dvcs
New Zealand: Draft Recall Procedure – Medicines & Medical Dvcs – Comments Due by Aug 27, 2010 http://ht.ly/2rYmM
IMB (Ireland) Advisory Notice Effective Traceability Med Dvcs
Irish Medicines Board Advisory Notice Effective Traceability of #Medical Devices issued Aug 13, 2010 pdf version http://ht.ly/2rCjc or html version http://ht.ly/2rCjz
FDA Recognizes ANSI/AAMI ES60601-1:2005 Version of Med Elect Equip Std
#FDA Recognizes ANSI/AAMI ES60601-1:2005 Version of Medical Electrical Equipment Standard http://ht.ly/2oiBH